Recall Z-2386-2016— Integra LifeSciences Corp.

Name: FDA recall Z-2386-2016
Creator: U.S. Food and Drug Administration
Published: 2016-07-20

Class II · Terminated

Class II FDA medical device recall by Integra LifeSciences Corp., initiated 2016-07-20, terminated 2016-12-16. It names 2 FDA 510(k) clearances: K160830, K140463. Product: Integra External Fixation System Universal Wire Fixation Bolt - 17.5 mm Catalogue #12224218 ; Integra External Fixation System Universal Wire Fixation Bolt - 23 mm Catalogue #12224219. Reason: Through the investigation of reported complaints Integra verified that there have been instances where the Universal Wire Fixation Bolts the Slotted Post broke during use at the surgical site..

Recalling firm: Integra LifeSciences Corp.
Classification: Class II
Status: Terminated
Initiated: 2016-07-20
Terminated: 2016-12-16
Firm location: Plainsboro, NJ, United States

510(k) clearances named in this recall

2 on FDA's record

K160830 — Integra External Fixation SystemAscension Orthopedics·cleared 2016-07-06
K140463 — INTEGRA EXTERNAL FIXATION SYSTEMAscension Orthopedic·cleared 2014-10-10

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Integra External Fixation System Universal Wire Fixation Bolt - 17.5 mm Catalogue #12224218 ; Integra External Fixation System Universal Wire Fixation Bolt - 23 mm Catalogue #12224219

Reason for recall

Through the investigation of reported complaints Integra verified that there have been instances where the Universal Wire Fixation Bolts the Slotted Post broke during use at the surgical site.

Data sourced from openFDA. This site is unofficial and independent of the FDA.